FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV
May 16 2022 - 4:10PM
Business Wire
– All Clinical Studies Evaluating Injectable
Lenacapavir to Resume –
– Decision Based on Review of Vial
Compatibility Data –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S.
Food and Drug Administration (FDA) has lifted the clinical hold
placed on the company’s Investigational New Drug Application (IND)
to evaluate injectable lenacapavir for HIV treatment and HIV
pre-exposure prophylaxis (PrEP). As previously announced, the FDA
had placed a clinical hold on the use of injectable lenacapavir in
borosilicate vials due to a vial compatibility issue. FDA removed
the clinical hold following the agency’s review of Gilead’s
comprehensive plan and corresponding data on the storage and
compatibility of lenacapavir injection with an alternative vial
made from aluminosilicate glass.
Following today’s decision from the FDA, all activity can resume
in the clinical studies evaluating injectable lenacapavir for HIV
treatment and HIV PrEP. During the clinical hold, screening and
enrollment of study participants and the dosing of injectable
lenacapavir were not permitted across all lenacapavir studies.
Other study activities, including the monitoring of participants,
the dosing of participants in comparator arms, and the dosing of
oral formulations of lenacapavir continued according to the
relevant study protocol. Gilead will now work with study site
investigators to fully resume the lenacapavir clinical development
programs as quickly as possible.
“We are pleased to have identified an alternative vial for
lenacapavir, and to now advance the robust clinical program for
this potential first-in-class long-acting option for HIV treatment
and prevention,” said Merdad Parsey, MD, PhD, Chief Medical
Officer, Gilead Sciences. “Today’s news brings us one step closer
to our goal of offering therapeutic options for the diverse
communities affected by HIV as we work to end the epidemic for
everyone, everywhere.”
In May 2019, the FDA granted Breakthrough Therapy Designation
for the development of lenacapavir for the treatment of HIV
infection in heavily treatment-experienced patients with multi-drug
resistance in combination with other antiretroviral drugs.
Lenacapavir recently received a complete response letter (CRL) for
its new drug application (NDA) in this population due to vial
compatibility. Gilead is working with the FDA to discuss next steps
for the potential use of lenacapavir for the treatment of HIV in
this population. Lenacapavir is an investigational compound and is
not approved by any regulatory authority for any use and its safety
and efficacy are not established. There is no cure for HIV or
AIDS.
About Lenacapavir
Lenacapavir is Gilead’s potential first-in-class,
investigational long-acting HIV-1 capsid inhibitor in development
for the treatment and prevention of HIV-1 infection. Lenacapavir’s
multi-stage mechanism of action is distinguishable from currently
approved classes of antiviral agents and is designed to provide a
new avenue for the development of long-acting therapy options for
people living with or at risk for HIV-1. While most antivirals act
on just one stage of viral replication, lenacapavir is designed to
inhibit HIV-1 at multiple stages of its lifecycle and has no known
cross resistance to other existing drug classes. If approved,
lenacapavir would be the only HIV-1 treatment option administered
twice yearly.
The safety, efficacy and dosing of Gilead’s investigational,
long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated
in multiple ongoing clinical studies, including CAPELLA, a Phase
2/3, double-blinded, placebo-controlled global multicenter study
designed to evaluate the antiviral activity of lenacapavir
administered every six months as a subcutaneous injection in
heavily treatment-experienced people with multi-drug resistant
HIV-1 infection. The New England Journal of Medicine published the
primary outcome results of the CAPELLA trial in its May 11, 2022
issue. (Capsid Inhibition with Lenacapavir in Multidrug-Resistant
HIV-1 Infection). Through week 26, lenacapavir was generally well
tolerated in CAPELLA, with no serious adverse events related to
lenacapavir as determined by the study investigator. The most
common adverse event observed in the trial was injection-site
reactions.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer.
For 35 years, Gilead has been a leading innovator in the field
of HIV, driving advances in treatment, prevention and cure
research. Gilead researchers have developed 11 HIV medications,
including the first single-tablet regimen to treat HIV and the
first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce
the risk of acquiring HIV infection. These advances in medical
research have helped to transform HIV into a preventable, chronic
condition for millions of people.
Gilead is committed to continued scientific innovation to
provide solutions for the evolving needs of people affected by HIV
around the world. Through partnerships and collaborations, the
company also aims to improve education, expand access and address
barriers to care, with the goal of ending the HIV epidemic for
everyone, everywhere.
Gilead operates in more than 35 countries worldwide, with
headquarters in Foster City, California.
Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to initiate, progress and complete
clinical trials involving lenacapavir in the anticipated timelines
or at all; the possibility of unfavorable results from ongoing and
additional clinical trials involving lenacapavir; uncertainties
relating to regulatory applications and related filing and approval
timelines, including Gilead’s ability to address the CRL to the
satisfaction of the FDA and the risk that FDA may not approve the
NDA for lenacapavir for the treatment of HIV infection in heavily
treatment-experienced patients with multi-drug resistance in a
timely manner or at all; the risk that any regulatory approvals, if
granted, may be subject to significant limitations on use; the
possibility that Gilead may make a strategic decision to
discontinue development of lenacapavir and as a result, lenacapavir
may never be successfully commercialized; and any assumptions
underlying any of the foregoing. These and other risks,
uncertainties and factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2022,
as filed with the U.S. Securities and Exchange Commission. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
reader is cautioned that any such forward-looking statements are
not guarantees of future performance and involve risks and
uncertainties, and is cautioned not to place undue reliance on
these forward-looking statements. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation and disclaims any intent to update any such
forward-looking statements.
GILEAD and the GILEAD logo are trademarks of
Gilead Sciences, Inc.
For more information about Gilead, please visit
the company’s website at www.gilead.com , follow Gilead on Twitter
(@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
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Jacquie Ross, Investors (408) 656-8793 Brian Plummer, Media
(650) 524-7708
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